(30 days)
The Transtek Glass Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.
Transtek Glass Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water, muscle mass and bone mass. The electrical current is low and may not be felt. The current passes freely through the fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed 'Bioelectrical Impedance', and is accurately measured by Glass Body Fat Analyzer LS206-E. This method simultaneously calculates your personal weight, body fat, total body water, muscle mass and bone mass, giving you a more accurate reading of your overall health and fitness. This scale stores the personal data of up to 4 users. As well as being an analyzer, this device can be used as a conventional weight scale. Transtek Glass Body Fat Analyzer LS206-E embeds a Wireless network connections module that allows it to connect to nearby receiving end (such as specific equipment that named Bridge) which is connected to the Internet. Once measurement is over, the LCD of device displays results. And the device will start to send out data. The Bridge receive / storage, and transmission data to Internet server. Thus users can receive, and display/storage, measurement results from LS206-E unit through their end devices (e.g. PC, cellular, tablet) that connected Internet.
The provided text describes a 510(k) premarket notification for the "TRANSTEK Glass Body Fat Analyzer Model: LS206-E". It focuses on establishing substantial equivalence to a predicate device, the TRANSTEK Glass Body Fat Analyzer, Model GBF-950-D (K112932).
Crucially, the document explicitly states: "Explanation: The new wireless function does not affect body analyzer measurement function. Therefore we have not done the Clinical test." This means no clinical study was performed to demonstrate the device meets acceptance criteria related to its core measurement functions (body fat, total body water, muscle mass, bone mass). The focus of the submission and the performance tests summary is on the safety and effectiveness of the wireless function integration and compliance with electrical and EMI standards, not on the accuracy of the body composition measurements.
Therefore, I cannot provide acceptance criteria or a study proving the device meets those criteria for the body composition analysis function based on the given information.
However, based on the information provided, here's what can be inferred and stated regarding performance and testing related to the wireless functionality and general device safety:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (Inferred from submission) | Reported Device Performance (From submission) |
|---|---|---|
| Wireless Functionality | Transmission of measurement results to internet-connected end devices (PC, cellular, tablet). | The device "embeds a Wireless network connections module that allows it to connect to nearby receiving end (such as specific equipment that named Bridge) which is connected to the Internet. Once measurement is over, the LCD of device displays results. And the device will start to send out data. The Bridge receive / storage, and transmission data to Internet server. Thus users can receive, and display/storage, measurement results from LS206-E unit through their end devices (e.g. PC, cellular, tablet) that connected Internet." This functions as optional and independent from the body analyzer. |
| Electrical Safety | Compliance with IEC60601-1 standard for electrical safety. | "LS206-E conforms to the following standards: ... IEC60601-1, Electrical safety" |
| Electromagnetic Compatibility (EMC) | Compliance with IEC60601-1-2 standard for EMC. | "LS206-E conforms to the following standards: ... IEC60601-1-2, Electromagnetic compatibility" |
| FCC Radiation & RF Rules | Compliance with FCC Part 15 for EMI tests. | "LS206-E conforms to the following standards: ... FCC Part 15, EMI tests of FCC Radiation & RF rules and regulations" |
| Risk Management | Implementation of risk management practices for medical devices. | "LS206-E conforms to the following standards: ISO14971, Risk management to medical devices" |
| Impact on Core Function | The new wireless function does not affect the body analyzer measurement function in terms of safety and effectiveness. | "The new wireless function does not affect body analyzer measurement function. Therefore we have not done the Clinical test." "Thus the wireless data transmission function does not affect the safety and effectiveness of the body analyzer function." |
| Substantial Equivalence | Maintain substantial equivalence to predicate device (GBF-950-D). | "The Transtek Glass Body Fat Analyzer LS206-E is substantially equivalent to the predicate device GBF-950-D by having the identical indication for use, identical technologies, and an add-on function which does not impact the safety and effectiveness of the device." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not mention a "test set" for body composition measurements or a clinical study. The tests performed were "bench tests" related to design control, risk management, and verification for the device modifications (primarily the wireless function) and compliance with relevant standards. No specific sample size or data provenance is mentioned for these engineering/safety tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As no clinical test was performed to establish performance for body composition measurements, there were no experts establishing ground truth for such a test set. The submission focuses on engineering and regulatory compliance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test was performed for body composition measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a standalone body composition analyzer, not an AI-assisted diagnostic tool requiring human reader interpretation. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A "standalone" performance for the body composition analysis (BIA technology) is implied to be identical to the predicate device, K112932, as the new device's core measurement function is stated to be unchanged. The submission primarily addresses the standalone performance of the wireless communication module and its non-interference with the core function. No new standalone performance evaluation for the BIA algorithm itself was conducted for this submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the body composition measurements, this information is not provided in the summary, as no new clinical study was conducted. It is assumed the predicate device established its performance against some form of ground truth (e.g., DEXA or other established methods), but details are not present here.
For the wireless functionality and safety aspects, the "ground truth" is compliance with engineering standards (IEC, FCC, ISO) and verification that the wireless module performs its intended data transmission without negatively impacting the existing device functions. This "ground truth" is established through bench testing and adherence to published standard requirements.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that involves a training set in the conventional sense for its core function. The device uses BIA technology, which is based on established biophysical principles and algorithms, not a trainable model from a large dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI-based algorithm described in this submission.
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.